EP1325716B1 - Thoracic aneurysm repair prosthesis and system - Google Patents

Thoracic aneurysm repair prosthesis and system Download PDF

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Publication number
EP1325716B1
EP1325716B1 EP03250107A EP03250107A EP1325716B1 EP 1325716 B1 EP1325716 B1 EP 1325716B1 EP 03250107 A EP03250107 A EP 03250107A EP 03250107 A EP03250107 A EP 03250107A EP 1325716 B1 EP1325716 B1 EP 1325716B1
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EP
European Patent Office
Prior art keywords
prosthesis
stent
aneurysm
prostheses
gasket
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Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Expired - Lifetime
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EP03250107A
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German (de)
English (en)
French (fr)
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EP1325716A1 (en
Inventor
Donald F. Depalma
Clifford J. Dwyer
Robert P. Letendre
Kenneth S. Solovay
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Cordis Corp
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Cordis Corp
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    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
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Definitions

  • the present invention relates to devices for repairing aneurysms, and more particularly, to percutaneously and/or intraluminally delivered devices for repairing aneurysms, such as abdominal aortic aneurysms and thoracic aortic aneurysms.
  • An aneurysm is an abnormal dilation of a layer or layers of an arterial wall, usually caused by a systemic collagen synthetic or structural defect.
  • An abdominal aortic aneurysm is an aneurysm in the abdominal portion of the aorta, usually located in or near one or both of the two iliac arteries or near the renal arteries. The aneurysm often arises in the infrarenal portion of the diseased aorta, for example, below the kidneys.
  • a thoracic aortic aneurysm is an aneurysm in the thoracic portion of the aorta. When left untreated, the aneurysm may rupture, usually causing rapid fatal haemorrhaging.
  • Aneurysms may be classified or typed by their position as well as by the number of aneurysms in a cluster. Typically, abdominal aortic aneurysms may be classified into five types.
  • a Type I aneurysm is a single dilation located between the renal arteries and the iliac arteries. Typically, in a Type I aneurysm, the aorta is healthy between the renal arteries and the aneurysm and between the aneurysm and the iliac arteries.
  • a Type II A aneurysm is a single dilation located between the renal arteries and the iliac arteries.
  • the aorta is healthy between the renal arteries and the aneurysm, but not healthy between the aneurysm and the iliac arteries.
  • the dilation extends to the aortic bifurcation.
  • a Type II B aneurysm comprises three dilations. One dilation is located between the renal arteries and the iliac arteries.
  • the aorta is healthy between the aneurysm and the renal arteries, but not healthy between the aneurysm and the iliac arteries.
  • the other two dilations are located in the iliac arteries between the aortic bifurcation and the bifurcations between the external iliacs and the internal iliacs.
  • the iliac arteries are healthy between the iliac bifurcation and the aneurysms.
  • a Type II C aneurysm also comprises three dilations. However, in a Type II C aneurysm, the dilations in the iliac arteries extend to the iliac bifurcation.
  • a Type III aneurysm is a single dilation located between the renal arteries and the iliac arteries.
  • the aorta is not healthy between the renal arteries and the aneurysm. In other words, the dilation extends to the renal arteries.
  • a ruptured abdominal aortic aneurysm is presently the thirteenth leading cause of death in the United States.
  • the routine management of abdominal aortic aneurysms has been surgical bypass, with the placement of a graft in the involved or dilated segment.
  • resection with a synthetic graft via transperitoneal or retroperitoneal procedure has been the standard treatment, it is associated with significant risk.
  • complications include perioperative myocardial ischemia, renal failure, erectile impotence, intestinal ischemia, infection, lower limb ischemia, spinal cord injury with paralysis, aorta-enteric fistula, and death.
  • Surgical treatment of abdominal aortic aneurysms is associated with an overall mortality rate of five percent in asymptomatic patients, sixteen to nineteen percent in symptomatic patients, and is as high as fifty percent in patients with ruptured abdominal aortic aneurysms.
  • Disadvantages associated with conventional surgery include an extended recovery period associated with the large surgical incision and the opening of the abdominal cavity, difficulties in suturing the graft to the aorta, the loss of the existing thrombosis to support and reinforce the graft, the unsuitability of the surgery for many patients having abdominal aortic aneurysms, and the problems associated with performing the surgery on an emergency basis after the aneurysm has ruptured.
  • the typical recovery period is from one to two weeks in the hospital, and a convalescence period at home from two to three months or more, if complications ensue. Since many patients having abdominal aortic aneurysms have other chronic illnesses, such as heart, lung, liver and/or kidney disease, coupled with the fact that many of these patients are older, they are less than ideal candidates for surgery.
  • aneurysms The occurrence of aneurysms is not confined to the abdominal region. While abdominal aortic aneurysms are generally the most common, aneurysms in other regions of the aorta or one of its branches are possible. For example, aneurysms may occur in the thoracic aorta. As is the case with abdominal aortic aneurysms, the widely accepted approach to treating an aneurysm in the thoracic aorta is surgical repair, involving replacing the aneurysmal segment with a prosthetic device. This surgery, as described above, is a major undertaking, with associated high risks and with significant mortality and morbidity.
  • Stent-grafts or endoprostheses are now FDA approved and commercially available. Their delivery procedure typically involves advanced angiographic techniques performed through vascular accesses gained via surgical cutdown of a remote artery, which may include the common femoral or brachial arteries. Over a guidewire, the appropriate size introducer will be placed. The catheter and guidewire are passed through the aneurysm. Through the introducer, the stent-graft will be advanced to the appropriate position. Typical deployment of the stent-graft device requires withdrawal of an outer sheath while maintaining the position of the stent-graft with an inner-stabilizing device.
  • stent-grafts are self-expanding; however, an additional angioplasty procedure, e.g., balloon angioplasty, may be required to secure the position of the stent-graft. Following the placement of the stent-graft, standard angiographic views may be obtained.
  • additional angioplasty procedure e.g., balloon angioplasty
  • arteriotomy closure typically requires open surgical repair.
  • Some procedures may require additional surgical techniques, such as hypogastric artery embolisation, vessel ligation, or surgical bypass, in order to adequately treat the aneurysm or to maintain flow to both lower extremities.
  • additional surgical techniques such as hypogastric artery embolisation, vessel ligation, or surgical bypass, in order to adequately treat the aneurysm or to maintain flow to both lower extremities.
  • additional, advanced catheter directed techniques such as angioplasty, stent placement, and embolisation, in order to successfully exclude the aneurysm and efficiently manage leaks.
  • US-5993481 discusses a modular bifurcated graft.
  • the modular system includes a primary graft, a graft having a hollow, generally Y-shaped structure attached to the primary graft, and two second grafts attached to the hollow, generally Y-shaped graft.
  • EP 1086665 discloses a modular graft with first anchoring prosthesis two stent grafts attached to first prosthesis, each having an anchoring stent at the distal end for anchoring in the two legs of a bifurcation.
  • endoprostheses represent a significant improvement over conventional surgical techniques
  • One concern with the use of endoprostheses is the prevention of endo-leaks and the disruption of the normal fluid dynamics of the vasculature.
  • Devices using any technology should preferably be simple to position and reposition as necessary, should preferably provide an acute fluid tight seal, and should preferably be anchored to prevent migration without interfering with normal blood flow in both the aneurysmal vessel as well as branching vessels.
  • devices using the technology should preferably be able to be anchored, sealed, and maintained in bifurcated vessels, tortuous vessels, highly angulated vessels, partially diseased vessels, calcified vessels, odd shaped vessels, short vessels, and long vessels.
  • the endoprostheses should preferably be extendable and re-configurable while maintaining acute and long term fluid tight seals and anchoring positions.
  • the endoprostheses should also preferably be able to be delivered percutaneously utilizing catheters, guidewires and other devices which substantially eliminate the need for open surgical intervention. Accordingly, the diameter of the endoprostheses in the catheter is an important factor. This is especially true for aneurysms in the larger vessels, such as the thoracic aorta.
  • the thoracic aneurysm repair prosthesis of the present invention provides a means for overcoming the problems associated with percutaneously delivering, anchoring and/or sealing at least one by-pass prosthesis in a large diameter artery as briefly described above.
  • a system for repairing an aneurysm in a large blood vessel as defined in appended claim 1.
  • the system includes a first prosthesis for sealing a proximal portion of the system within a portion of an artery upstream of an aneurysm; a second prosthesis for anchoring a distal portion of the system within a portion of an artery downstream of the aneurysm; and at least two third prostheses or bypass matingly engaged within the first prosthesis and extending through and beyond the portion of the artery in need of repair or replacement.
  • the third prostheses are also be matingly engaged within the second prosthesis.
  • a typical first prosthesis includes a support or stent structure, and a foam or gasket material supported by the stent, the stent and gasket material being configured to seal the system within an artery.
  • a typical first prosthesis also includes one or more structures or elements for engaging the third prosthesis. In preferred embodiments of the invention, these elements or structures sealingly and/or matingly engage the third prosthesis.
  • the stent is typically a synthetic or natural matrix for supporting the gasket material.
  • the stent is a hollow, substantially cylindrical, and preferably radially expandable matrix having a lumen and two open ends.
  • the typical gasket material is a synthetic or natural fabric, tissue, foam, or the like. In preferred embodiments of the invention, the gasket material covers at least a portion of the lumen, even more preferably, the proximal end of the lumen.
  • the typical third prosthesis of the present invention includes a support or stent structure, and graft material supported by the stent, the stent and graft material defining a fluid flow path therethrough.
  • the typical graft material is a synthetic or natural fabric, tissue, or the like.
  • the stent is typically a synthetic or natural matrix for supporting the graft and/or positioning the prosthesis in a pre-determined position.
  • the stent is a hollow, substantially cylindrical, and preferably radially expandable matrix having a lumen and two open ends.
  • the stent typically comprises a plurality of interconnected struts.
  • a graft material may be positioned on an inside and/or outside surface of the matrix; in preferred embodiments of the invention, the graft material may include a plurality of substantially longitudinally directed pleats disposed thereon. In a particularly preferred embodiment, the graft further includes a plurality of radially oriented pleat interruptions. In some embodiments of the invention the graft material may be attached to the stent, preferably by one or more staples or the like.
  • a system according to the present invention is intended for repairing or bypassing an aneurysm, preferably an aortic aneurysm in the thoracic region.
  • the system may also be used to direct fluid flow from one portion of a fluid pathway to another.
  • the typical system according to the present invention may include multiple system components, e.g., more than one prosthesis, with the first prosthesis typically positioned upstream of an aneurysm.
  • the first prosthesis, or stent gasket includes one or more structures or elements that seal the system in the artery, and prevent fluid flow between the system and an arterial wall.
  • the first prosthesis also preferably includes gasket material configured and adapted to facilitate delivery of other system components, to receive and/or position other system components, and/or to seal the system.
  • a system may include a first prosthesis configured to be positioned in an artery upstream of an aneurysm, and a third prosthesis that matingly engages the first prosthesis and provides a fluid flow path that bypasses the aneurysm.
  • the system may include a variety of other components all adapted to communicate with another component in the system, with a particular assembly of components designed to establish one or more fluid flow paths that bypass a pre-determined location, e.g., a location that includes an aneurysm and/or an arterial junction.
  • the apparatus, systems and kits of the present invention may be used in the treatment of aortic aneurysms, preferably a thoracic aortic aneurysm, among other uses noted below.
  • aortic aneurysms preferably a thoracic aortic aneurysm
  • a better understanding of the present device and its use in treating thoracic aortic aneurysms will be achieved by reading the following description in conjunction with the above-incorporated references.
  • the present invention is directed to a system comprising one or more components for repairing or bypassing an aneurysm, preferably an aneurysm located in a large blood vessel.
  • the system includes one or more prostheses for sealing the system upstream and downstream of the aneurysm.
  • the system may include a first prosthesis for anchoring the system upstream of the aneurysm, a second prosthesis for anchoring the system downstream of the aneurysm, and two or more third prostheses communicating with the first prosthesis and the second prosthesis, and establishing at least two fluid flow paths through the aneurysm.
  • Each of the first and second prostheses may comprise a gasket material engaging a stent, the stent optionally including at least one distally extending leg for positioning the stent in a portion of the artery.
  • Each of the first and second prostheses may also include one or more gaskets or other structures for sealing the system and for sealingly engaging at least one third prosthesis.
  • the third prosthesis may comprise a graft material engaging a stent, said third prosthesis defining a fluid flow path through or bypassing the aneurysm.
  • the system includes two third prostheses. All of the prostheses of the present invention may include a stent comprising a lattice or matrix having diamond shaped structures. A portion of the matrix may or may not include graft material engaging the matrix.
  • An exemplary embodiment of the present invention includes a first prosthesis, the first prosthesis comprising a gasket material engaging a stent, the stent comprising a matrix of interconnected struts configured to engage a section of an artery upstream of an aneurysm; a second prosthesis, the second prosthesis comprising a gasket material engaging a stent, the stent comprising a matrix of interconnected struts configured to engage a section of an artery downstream of an aneurysm; and two third prostheses interposed between the first prosthesis and the second prosthesis, and being configured for establishing a fluid flow channel through the aneurysm.
  • one or both of the first and second prostheses may include gasket material configured to receive at least one third prosthesis.
  • the first and second prostheses may be separate components, or the first and second prostheses may communicate with each other through one or more bridges or the like.
  • the gasket material is configured to receive two third prosthesis, each of the third prostheses preferably having a proximal end positioned in an artery upstream of the aneurysm, and a distal end positioned in an artery downstream of the aneurysm.
  • the present invention may also include a first prosthesis for repairing or bypassing an aneurysm, the first prosthesis comprising a gasket material engaging a stent and defining a fluid flow path therethrough, the stent comprising a matrix of interconnected struts, the first prosthesis being configured to engage a section of an artery upstream of an aneurysm; wherein a portion of the gasket material is positioned across the fluid flow path, the portion comprising at least one thread defining a predetermined region within the portion, the predetermined region configured to receive at least one third prosthesis, the third prostheses being configured for establishing a fluid flow channel through the aneurysm.
  • the portion includes a first thread defining a first predetermined region configured to receive a first third prosthesis, and a second thread defining a second predetermined region configured to receive a second third prosthesis.
  • Some embodiments of the invention may further include a portion further comprising a third thread defining a third predetermined region configured to receive a third third prosthesis, and a fourth thread defining a fourth predetermined region configured to receive a fourth third prosthesis.
  • the third and/or fourth third prostheses may be configured for establishing a fluid flow channel from a proximal portion of the first prosthesis and into a cross artery, such as the subclavian arteries or other vascular branches in the thoracic aorta.
  • the first and second prostheses may be configured in the same manner, i.e., include the same structures and/or elements.
  • Any of the prostheses or stents described above may form a component or portion of a system or kit for repairing or bypassing an aneurysm.
  • any of the prostheses, stents, systems, or kits described above may be incorporated in a method for treating an aneurysm.
  • the prostheses, stents, systems, or kits are used to treat an aortic aneurysm, even more preferably, an thoracic aortic aneurysm.
  • An exemplary method for treating an aneurysm using the system of the present invention can involve delivering and deploying a first prosthesis upstream of an aneurysm and a second prosthesis downstream of the aneurysm, the first prosthesis being adapted to receive a proximal portion of at least one third prosthesis; the second prosthesis being adapted to receive a distal portion of the third prosthesis; positioning a proximal end of at least one third prosthesis in a proximal end of the first prosthesis, and positioning a distal end of the third prosthesis in a distal portion of the second prosthesis.
  • the method includes delivering and deploying two third prostheses within the first and second prostheses.
  • Exemplary prostheses of the present invention may be configured to repair a thoracic aneurysm.
  • the first prosthesis may be positioned in a portion of an artery upstream of the aneurysm
  • the second prosthesis may be positioned in a portion of an artery downstream of the aneurysm.
  • the system of the present invention may be provided as a kit that includes one or more of the following: a sterile or sterilisable enclosure; a first prosthesis; a first prosthesis in an individual sterile enclosure; a second prosthesis; a second prosthesis in an individual sterile enclosure; a third prosthesis; a third prosthesis in an individual sterile enclosure; at least one suture; at least one staple; a collar or catheter tip assembly configured to engage and deliver a first prosthesis, a second prosthesis, and/or a third prosthesis; and at least one marker configured for placement on a first prosthesis, a second prosthesis, a third prosthesis, and/or portions thereof.
  • a system of the present invention may include one or more modular components.
  • a modular component is configured, or adapted to engage, or includes one or more structures that are intended to communicate with or engage a complementary structure on another modular component.
  • Embodiments of the present invention may further include two or more third prostheses configured to matingly engage a first prosthesis and/or a second prosthesis, the third or bypass prostheses comprising a graft material engaging a stent, the stent comprising a hollow matrix comprising a series of interconnected struts, the matrix being moveable from a first closed position to a second open position; the stent having at least one attachment structure or connector for matingly engaging at least one second complementary structure on the first prosthesis.
  • the prostheses further comprises at least one marker.
  • the marker or markers are positioned on or formed as part of the stent.
  • aortic aneurysm refers to any failure of a conduit, such as an aortic wall, typically characterized by an undesirable dilation of a portion of the artery, vessel malformation, or an occlusion.
  • the system and structures of the present invention may be used to treat, repair, replace, or bypass any blood vessel (e.g., artery, vein, capillary); any fluid carrying vessel (e.g., lymphatic vessels); any organ or portion thereof that includes a blood or fluid vessel; or any junction between blood vessels, between fluid vessels, and between organs and blood vessels.
  • An exemplary use of a system and method of the present invention is to repair an aortic aneurysm, and the use of such term is not intended to limit the use of the structures or systems of the present invention to repair or replace other conduit failures.
  • the prosthesis of the present invention may also be utilized in the thoracic aorta, and may be used to repair thoracic aneurysms or thoracic dissecting aneurysms. Accordingly, use of the term "aortic aneurysm" is intended to relate to and include other aneurysms, including but not limited to both abdominal aortic aneurysms and thoracic aneurysms.
  • the system and structures are used to treat, repair, replace, or bypass an aneurysm located in a large blood vessel, e.g., a blood vessel having a diameter of about 36 mm or more, such as a thoracic aneurysm.
  • a large blood vessel e.g., a blood vessel having a diameter of about 36 mm or more, such as a thoracic aneurysm.
  • fluid pathway refers to any in vivo structure through which a biological fluid passes.
  • a preferred fluid pathway is an artery.
  • Fluid pathways include, but are not limited to channels formed by an artery, a vein, a capillary, lymph nodes and channels, and arteries, veins, and capillaries within an organ or organelle.
  • fluid or biological fluid refers to any fluid produced by an animal, including a human.
  • exemplary biological fluids include but are not limited to blood, oxygenated blood, de-oxygenated blood, gastric fluids, amniotic fluid, spinal fluid, and lymph.
  • the preferred fluid is blood or oxygenated blood.
  • conduit typically refers to any structure used to convey a biological fluid.
  • the conduit may be formed of natural or synthetic materials, or combinations thereof.
  • Exemplary conduits include but are not limited to an artery, a vein, a capillary, lymph nodes and channels, and arteries, veins, capillaries within an organ or organelle, and a prosthesis or system according to the invention.
  • biofusion refers to the ability of cells, proteins, fibrin, and other biological molecules to incorporate into the pore structure of a material, such as a foam or gasket material, or a graft material. It is believed that this feature promotes a long term stable biological interface that cannot be separated about six weeks after implantation.
  • biofusion effect has many advantages. It has the potential to obviate late endo-leakage by preventing areas of non-organized clot from being displaced or recanalised. It is also believed that biofusion creates a connective tissue collar around the prosthesis that may prevent the aortic neck from dilating over time. Restricting neck dilation avoids leakage pathways and implant migration that can be caused by an insufficient fit with the aorta.
  • adapted for communication, communicating, or similar terms refer to any means, structures, or methods for establishing operational association between two elements of the system.
  • engaging, adapted to engage, or similar terms refer to means, structures, or methods for contacting a first component, structure, or portion thereof with a second component, structure, or portion thereof.
  • Exemplary structures are shown in the figures. Typically, all of these terms and phrases refer to at least one structure in or on a first component configured to engage a complementary structure in or on a second component, and the use of these inter-engaging features to link a first prosthesis or component with a second prosthesis or component.
  • the engagement or communication may be matingly (e.g., permanent) and/or releasably (e.g., temporary). In preferred embodiments of the invention, communication or engagement may be fluid tight, substantially fluid tight, or fluid tight to an extent so as to not substantially compromise the intended function of the structure.
  • a connector may be adapted to receive or connect to a complementary connector on another prosthesis.
  • connector refers to any structure used to form a joint or to join itself to another component or portion thereof.
  • These connectors or connections establish a fluid flow path through various elements of the apparatus, assembly, or system.
  • the system is intended to establish at least one fluid flow path through a vessel, conduit, organ, or portions thereof.
  • Typical connections include but are not limited to mating connections, such as Luer-type, screw-type, friction-type, or connectors that are bonded together.
  • distal is used in accordance with its ordinary dictionary definition, e.g., referring to a position farthest from the beginning; in human anatomy, this term is commonly equivalent to caudal or inferior.
  • Proximal is used in accordance with its ordinary dictionary definition, e.g., referring to a position nearest the beginning; in human anatomy, this term is commonly equivalent to cranial or superior.
  • the terms distal and proximal are intended to convey opposite ends or portions of a device, channel, element, or structure. In relation to a fluid flow path, distal will typically refer to a downstream location in the fluid flow path, and proximal will typically refer to an upstream location, unless otherwise specifically noted. Anatomically, distal generally refers to "away from the heart” and proximal generally refers to "toward the heart”.
  • a system for treating an aortic aneurysm typically includes a first prosthesis, a second prosthesis that may or may not communicate with the first prosthesis, and at least one third prosthesis positioned or anchored by the first and second prostheses.
  • the components of the system are delivered intraluminally to the site of the aneurysm using a catheter or the like.
  • a catheter or the like One skilled in the art will therefore recognize that it is beneficial to deliver the components of the system in a closed or first position, and to deploy the component in its functional location by expanding the component into an open or second position.
  • the component is self-expanding; that is, once the component is released from its delivery device, the component automatically moves into its open position.
  • the component may be expandable using a balloon or the like, as is well known to those skilled in the art.
  • a typical second prosthesis forms a fluid flow channel that bypasses the aneurysm.
  • the system may also include at least one third prosthesis, typically forming a fluid flow path into a cross artery upstream of the aneurysm.
  • the system includes a first prosthesis 10a, a second prosthesis 10b, and two third prostheses 11a and 11b, which, in combination, bypass an aneurysm 100.
  • a proximal portion of the system may be positioned in a section 101 of an artery upstream of the aneurysm 100, and a distal portion of the system may be positioned in a down stream section 102 of the artery.
  • a prosthesis used in a system of the present invention typically includes a support, stent, or lattice of interconnected struts defining an interior space or lumen having an open proximal end and an open distal end.
  • the lattice also defines an interior surface and an exterior surface.
  • the interior and/or exterior surfaces of the lattice, or a portion of the lattice may be covered by or support at least one covering material, such as a foam or graft material.
  • some prostheses of the present invention may be configured to seal and/or anchor the system in place, and/or to receive and position other prostheses.
  • these prostheses do not themselves define a fluid flow path.
  • Other prostheses may be configured to define at least one fluid flow path.
  • these prostheses define a channel or the like through which fluid, such as blood, flows. This channel or fluid flow path typically begins upstream of, or in an upstream portion of, a component of the system. In some embodiments of the invention, the fluid flow path bypasses the aneurysm.
  • a prosthesis is moveable between an expanded or inflated position and an unexpanded or deflated position, and any position therebetween.
  • Such capability is beneficial to the surgeon to properly position or re-position the prosthesis.
  • the prosthesis may be self-expanding, or may be expandable using an inflatable device, such as a balloon or the like.
  • a delivery apparatus for a prosthesis includes an outer sheath, comprising an elongated tubular member having distal and proximal ends, and an inner shaft located coaxially within the outer sheath, the shaft having a distal end and a proximal end.
  • the distal end of the shaft further including at least two grooves disposed thereon.
  • the flanges of the first prosthesis are configured to releasably engage the grooves of a portion of the delivery device.
  • the first prosthesis 10a is deployed in a portion 101 of the artery upstream of the aneurysm
  • the second prosthesis 10b is deployed in a portion 102 of the artery downstream of the aneurysm.
  • Figure 1 also shows two third prostheses, 11a and 11b, the proximal ends of which matingly engage a proximal portion of first prosthesis 10a, and the distal ends of which matingly engage a distal portion of second prosthesis 10b.
  • the body of the third prosthesis forms a conduit or fluid flow path that passes through the location of the aneurysm 100.
  • the components of the system define a fluid flow path that bypasses the section of the artery where the aneurysm is located.
  • the first prosthesis includes a support matrix or stent that supports a sealing material or foam, at least a portion of which is positioned across a biological fluid flow path, e.g., across a blood flow path.
  • the first prosthesis, the stent, and the sealing material are radially expandable, and define a hollow space between a proximal portion of the prosthesis and a distal portion of the prosthesis.
  • the first prosthesis may also include one or more structures for positioning and anchoring the prosthesis in the artery, and one or more structures for engaging and fixing at least one second prosthesis in place, e.g., a bypass prosthesis.
  • the support matrix or stent of the first prosthesis may be formed of a wide variety of materials, may be configured in a wide variety of shapes, and their shapes and uses are well known in the art. Exemplary prior art stents are disclosed in US-4733665 (Palmaz ), US-4739762 (Palmaz ), and US-4776337 (Palmaz ).
  • the stent of the first and second prosthesis is a collapsible, flexible, and self-expanding lattice or matrix formed from a metal or metal alloy, such as nitinol or stainless steel. Structures formed from stainless steel may be made self-expanding by configuring the stainless steel in a predetermined manner, for example, by twisting it into a braided configuration. More preferably, the stent is a tubular frame that supports a sealing material.
  • tubular refers to any shape having a sidewall or sidewalls defining a hollow space or lumen extending therebetween; the cross-sectional shape may be generally cylindrical, elliptic, oval, rectangular, triangular, or any other shape. Furthermore, the shape may change or be deformable as a consequence of various forces that may press against the stent or prosthesis.
  • the sealing material or gasket member supported by the stent may be formed of a wide variety of materials, may be configured in a wide variety of shapes, and their shapes and uses are well known in the art. Exemplary materials for use with this aspect of the invention are disclosed in US-4739762 (Palmaz ) and US-4776337 (Palmaz ).
  • the sealing material or gasket member may comprise any suitable material.
  • Exemplary materials are composed of a biodurable and biocompatible material, including but are not limited to, open cell foam materials and closed cell foam materials.
  • Exemplary materials include polyurethane, polyethylene, polytetrafluoroethylene; and other various polymer materials, preferably woven or knitted, that provide a flexible structure, such as a polyester (such as that sold under the trade mark Dacron).
  • Highly compressible foams are particularly preferred, preferably to keep the crimped profile low for better delivery.
  • the sealing material or foam is preferably substantially impervious to blood when in a compressed state.
  • the sealing material may cover one or more surfaces of the stent i.e., can be located along an interior or exterior wall, or both, and preferably extends across the proximal end or a proximal portion of the stent.
  • the sealing material helps impede any blood trying to flow around the first prosthesis, e.g., between the first prosthesis and the arterial wall, and around the third prostheses after they have been deployed within the lumen of the first prosthesis (described in more detail below).
  • the sealing material stretches or covers a portion of the proximal end of the stent and along at least a portion of the outside wall of the stent.
  • the portion of the sealing material covering the proximal portion of the stent may include one or more holes, apertures, points, slits, sleeves, flaps, weakened spots, guides, or the like for positioning a guidewire, for positioning a system component, such as a second prosthesis, and/or for engaging, preferably matingly engaging, one or more system components, such as a second prosthesis.
  • a sealing material configured as a cover or the like, and having a hole may partially occlude the stent lumen.
  • openings may be variously configured, primarily to conform to its use. These structures promote proper side by side placement of one or more, preferably multiple, prostheses within the first prosthesis, and, in some embodiments of the invention, the sealing material may be configured or adapted to assist in maintaining a certain shape of the fully deployed system or component. Further, these openings may exist prior to deployment of the prosthesis, or may be formed in the prosthesis as part of a deployment procedure. The various functions of the openings will be evident from the description below.
  • the sealing material is a foam cover that has a single hole.
  • the sealing material may be attached to the stent by any of a variety of connectors, including a plurality of conventional sutures of polyvinylidene fluoride, polypropylene, polyester (such as that sold under the trade mark Dacron), or any other suitable material and attached thereto.
  • Other methods of attaching the sealing material to the stent include adhesives, ultrasonic welding, mechanical interference fit and staples.
  • One or more markers may be optionally disposed in or on the stent between the proximal end and the distal end.
  • two or more markers are sized and/or positioned to identify a location on the prosthesis, or to identify the position of the prosthesis, or a portion thereof, in relation to an anatomical feature or another system component.
  • the first prosthesis is typically deployed in an arterial passageway upstream of an aneurysm, and functions to open and/or expand the artery, to properly position and anchor the various components of the system, and, in combination with other components, seal the system or portions thereof from fluid leaks.
  • the first prosthesis seals the system from leakage between the system and the arterial wall, and from leakage between the first prosthesis and the third prosthesis.
  • the second prosthesis is typically deployed in an arterial passageway downstream of an aneurysm, and functions to open and/or expand the artery, to properly position and anchor the various components of the system, and, in combination with other components, seal the system or portions thereof from fluid leaks.
  • the second prosthesis seals the system from retrograde flow or leakage.
  • FIGS 1 to 3 show an exemplary sealing prosthesis 10a, b of the present invention.
  • Sealing prosthesis 10a, b includes a cylindrical or oval cross-sectional self-expanding lattice, support, or stent 12, typically made from a plurality of interconnected struts 13.
  • Stent 12 defines an interior space or lumen 18 having two open ends, a proximal end 14 and a distal end 16.
  • markers 15 may be optionally disposed in or on the stent between the proximal end 14 and the distal end 16.
  • Stent 12 may further include at least two, but preferably eight (as shown in Figure 2), spaced apart longitudinal legs 20. Preferably, there is a leg extending from each apex 11 of diamonds formed by struts 13. At least one leg, but preferably each leg, includes a flange 28 adjacent its distal end which, as is described in greater detail below, allows for the stent to be retrievable into its delivery apparatus after partial or nearly full deployment of stent 12 so that it can be turned, or otherwise repositioned for proper alignment.
  • FIG 3 shows the sealing material 30 covering the proximal end of stent gasket 10.
  • sealing prosthesis 10 includes a sealing material 30 having a first opening or hole 32 and a second opening or slit 33.
  • the gasket material covers at least a portion of the interior or exterior of the stent, and most preferably covers substantially all of the exterior of the stent.
  • gasket material 30 may be configured to cover stent 12 from the proximal end 16 to the distal end 14, but preferably not covering longitudinal legs 20.
  • sealing material 30 helps impede any blood trying to flow around third prostheses 11a and 11b after they have been deployed (as shown in Figure 1), and from flowing around the stent gasket itself.
  • sealing material 30 is a compressible member or gasket located along the exterior of the stent 12 and at least a portion of the interior of the stent 12.
  • FIGS 6 and 7a to 7c show a first prosthesis 10a having a gasket material 30 that covers at least a portion of the proximal end of the first prosthesis 10a.
  • the gasket material 30 preferably includes a partition that extends approximately across the diameter of the cross section of the first prosthesis 10a, wherein the partition includes a thicker gasket material, or further includes a foam or the like.
  • the partition may be formed from any of the gasket or foam materials described above.
  • the partition defines at least one section 72 within the prosthesis having less material or the like, these sections being configured for receiving a proximal end of a third prosthesis, as is described in more detail below.
  • partition 71 defines a first section 72a and a second section 72b; first section 72a is configured to receive a first third prosthesis 11a, and second section 72b is configured to receive a second third prosthesis 11b, as described below.
  • fibres, threads, filaments, straps, or the like may be desirable to include one or more fibres, threads, filaments, straps, or the like for further defining a section 72.
  • the word fibre or thread will be used as a shorthand descriptor for the element that includes fibres, threads, filaments, straps, or the like.
  • the fibre, etc. assists in positioning a third prosthesis 11a,b.
  • the fibre or thread may be formed from any material and/or comprise any construction suitable for use in a biological environment, e.g., suitable for use in a blood vessel.
  • the fibre may be woven or non-woven, formed of a synthetic or natural material, and/or single or multi-filament.
  • Exemplary materials for forming the fibre include but are not limited to polyester, polyester (such as that sold under the trade mark Dacron), polytetrafluoroethylene (such as that sold under the trade mark Teflon), polyurethane, porous polyurethane, silicone, polyethylene terephthalate, and expanded polytetrafluoroethylene (ePTFE).
  • the fibre or thread may also take on other forms.
  • the fibre or thread may be formed from glues or adhesives, or by melting sections of the gasket material.
  • the fibres or thread may comprise struts deformed out of the circumferential plane.
  • the end or ends of the fibre may be unattached or attached. In a preferred embodiment of the invention, both ends of the fibre are attached or fixed. For example, the ends may be sewn or fixed to the cover 31. In a preferred embodiment of the invention, the ends of the fibre are fixed to a strut 13, even more preferably to a proximal portion of stent 12. One or more ends of the fibre may be fixed to the stent 12 or the strut 13 by threading, knotting, sewing, with adhesives, or any other mechanism for fixing the end of the fibre in place.
  • fibre 73 may be variously configured.
  • fibres 73a and 73b may be interwoven in the cover 31, and define or form first section 72a and a second section 72b, as noted above.
  • the ends of the fibres may be fixed to a strut; see 74a, 74b, 74c, and 74d.
  • a single fibre 73c may be positioned across the diameter of the cover 31, and is fixed to a strut at 74e and 74f.
  • one or more crossed fibres 73d and 73e may be used to form or define partitions 72a and 72b respectively.
  • the ends may be attached to the stent 12 at 74a, 74b, 74c, and 74d.
  • the fibre breaks as the unexpanded prosthesis is expanded to its fully deployed position.
  • the ends of the fibres may be releasably fixed to the stent or strut when the prosthesis is in a collapsed condition, with one or more ends releasing as the prosthesis expands to its fully deployed position.
  • first and second prostheses may be connected together or unconnected.
  • the bridge or plurality of struts that connect the two prostheses may be flexible or non-flexible.
  • Figure 8 illustrates an embodiment wherein the first and second prostheses are connected by a plurality of struts 800.
  • the bridge or struts 800 are flexible and capable of elongating longitudinally, i.e., increasing the overall length of the complete system.
  • the third prostheses are bypass conduits or the like that is typically deployed in an arterial passageway upstream of an aneurysm, and establishes a fluid flow path through the system or a portion thereof.
  • the third prosthesis defines a fluid flow path that passes through the arterial segment having the aneurysm, e.g., bypassing the aneurysm.
  • the third prosthesis extends from a healthy portion of the artery, through the arterial segment having the aneurysm, and into another healthy portion of the artery or another artery.
  • the third prosthesis functions to bypass the portion of the conduit containing the aneurysm, and to properly position and/or anchor the proximal end of the system in an artery.
  • the third prosthesis defines a fluid flow path from one portion of the system, e.g., a proximal portion or end, to another portion, e.g., a distal portion or end, or an intermediate portion.
  • the third prosthesis may also include one or more structures for positioning and anchoring the third prosthesis in the artery or in the first prosthesis.
  • the third prosthesis is adapted to engage the first and second prosthesis.
  • One or more markers may be optionally disposed in or on the stent between the proximal end and the distal end.
  • two or more markers are sized and/or positioned to identify a location on the prosthesis, or to identify the position of the prosthesis, or a portion thereof, in relation to an anatomical feature or another system component.
  • fluoroscopically identifiable sutures or staples are used; these sutures or staples may also attach the graft material to the stent.
  • the third prosthesis typically includes a support matrix or stent that supports a graft material.
  • One end of the third prosthesis is typically adapted to engage one or more portions of the first prosthesis.
  • the proximal end of third prosthesis is adapted to matingly engage a proximal portion of first prosthesis
  • the distal end of the third prosthesis is adapted to matingly engage a distal portion of second prosthesis.
  • the third prosthesis may optionally include at least one attachment structure on its distal end for engaging and securing the prosthesis in a portion of an artery downstream of the aneurysm.
  • FIGS 1 and 4 show an exemplary third or bypass prosthesis 11a,b of the present invention.
  • Third prosthesis 11a,b includes a substantially cylindrical self-expanding lattice, support, or stent 40, typically made from a plurality of interconnected struts 44.
  • Lattice 40 defines an interior space having two open ends, a proximal end 41 and a distal end 42.
  • the interior and/or exterior surfaces of lattice 40 may be covered by or support at least one graft material 60.
  • any of the stents of the present invention form a support or lattice structure suitable for supporting a graft material.
  • the stent defines a channel through which a fluid, such as blood, may flow.
  • a typical stent comprises an expandable lattice or network of interconnected struts.
  • the lattice is laser cut from an integral tube of material.
  • the stent may be variously configured.
  • the stent may be configured with struts or the like that form repeating geometric shapes.
  • a stent may be configured or adapted to include certain features and/or to perform a certain function(s), and that alternate designs may be used to promote that feature or function.
  • the struts form a matrix having diamond shapes.
  • the matrix or struts of stent 12 are configured into diamond shapes, having approximately eight diamonds.
  • the fully expanded diamond pattern of a first prosthesis has angles of about forty-five to fifty-five degrees at their distal and proximal ends.
  • the matrix or struts of stent 40 may be configured into at least two hoops 43, each hoop 43 comprising a number of struts 44 having a diamond shape, having approximately nine diamonds.
  • a third prosthesis such as third prosthesis 11a,b, may further include a zig-zag shaped ring 50 for connecting adjacent hoops to one another.
  • the zig-zag shaped rings may be formed from a number of alternating struts 52, wherein each ring has fifty-four struts.
  • the diamond pattern for the anchors, as well as the other hoops, provide the hoops with radial and longitudinal stiffness.
  • the longitudinal strength provides for better mechanical fixation of stent 40 to a graft material (described below).
  • the radial strength provides a proximal hoop 45 with better attachment and sealing to the graft material, and provides a distal hoop 46 with better fixation and sealing to the arterial wall. Further, the distal hoop may be flared, and may be exposed after the graft material has been attached to the stent.
  • the proximal and distal hoops have greater radial and longitudinal strength than the hoops therebetween.
  • the stiffer ends can be accomplished by changing the dimensions of the struts for the end hoops, or by varying the heat treatment of the end hoops during manufacture.
  • the rings allow the stent to bend more easily, and generally provide for more flexibility when the stent is being delivered through a tortuous vessel.
  • the strength of the diamond hoops scaffolds any graft folding into the blood flow lumen, while maintaining a tight kink radius.
  • the proximal and/or distal end of a stent may include one or more anchors and/or one or more struts of the stent configured into an anchor.
  • One or more anchors commonly referred to as recapture legs, may also be configured to releasably engage a delivery device, such as a catheter, or a portion thereof.
  • the distal end of the stent is preferably configured to engage a complementary structure on a delivery device, such as a catheter or a portion thereof.
  • a delivery device such as a catheter or a portion thereof.
  • the distal end of the stent may include one or more keys that engage, preferably releasably engage, a corresponding latch on the catheter.
  • An exemplary configuration is shown in Figure 2. It is intended that the invention should not be limited by the precise structures used to engage the stent to the delivery device.
  • the stent may include one or more anchors 28 configured to engage a corresponding structure on a delivery device 130 (shown in Figure 5).
  • the delivery apparatus may include a collar having one or more grooves or the like adapted to releasably engage one or more complementary structures on a stent or prosthesis of the present invention.
  • Such an anchor/delivery device configuration is particularly suited to partially deploying a prosthesis of the present invention, and to position or re-position the prosthesis.
  • any of the stents of the present invention may be formed of any material suitable for functioning in vivo as a support for graft material.
  • a stent of the present invention may be formed from a wide variety of materials, all of which are well known to those skilled in the art.
  • the stent is formed from a metal or metal alloy.
  • the stent is formed from superelastic Nickel Titanium alloys (Nitinol). Descriptions of medical devices which use such alloys can be found in US-4665906 and EP-A-928606 .
  • a stent according to the invention is preferably laser cut from a tubular piece of nitinol and thereafter treated so as to exhibit shape memory properties at body temperature.
  • the stent material is expandable or collapsible, i.e., moveable from a first closed position to a second open position, or vice versa.
  • Graft material 60 can be made from any number of materials known to those skilled in the art, including woven polyester, polyester (such as that sold under the trade mark Dacron), polytetrafluoroethylene (such as that sold under the trade mark Teflon), polyurethane, porous polyurethane, silicone, polyethylene terephthalate, expanded polytetrafluoroethylene (ePTFE) and blends of various materials.
  • a biodegradable, or degradable material such as albumin, collagen, or any type of collagen.
  • a graft material that is biodegradable would erode or dissolve over time; however, it is believed that the eroding graft material may be replaced by one or more biofusion constituents, or alternately, a layer of endothelium may grow as the graft material erodes. It is further believed that these new layers of endothelium may provide a new, fluid impervious lining within the aneurysm.
  • all of the foregoing materials be porous to allow for an intimal layer to form a biofusion structure or matrix.
  • the graft material may be variously configured, preferably to achieve predetermined mechanical properties.
  • the graft material may incorporate a single or multiple weaving and/or pleating patterns, or may be pleated or unpleated.
  • the graft may be configured into a plain weave, a satin weave, include continuous longitudinal pleats, interrupted pleats, annular or helical pleats, radially oriented pleats, or combinations thereof.
  • the graft material may be knitted or braided.
  • the pleats may be continuous or discontinuous.
  • the pleats may be oriented longitudinally, circumferentially, or combinations thereof.
  • graft material 60 may include a plurality of longitudinal pleats 61 extending along its surface, generally parallel to the longitudinal axis of the prosthesis.
  • the pleats allow the prosthesis to collapse around its centre, much as it would be when it is delivered into a patient. This provides a relatively low profile delivery system, and provides for a controlled and consistent deployment therefrom. It is believed that this configuration minimizes wrinkling and other geometric irregularities.
  • the prosthesis Upon subsequent expansion, the prosthesis assumes its natural cylindrical shape, and the pleats or folds uniformly and symmetrically open.
  • pleats 61 help facilitate stent graft manufacture, in that they indicate the direction parallel to the longitudinal axis, allowing stent to graft attachment along these lines, and thereby inhibiting accidental twisting of the graft relative to the stent after attachment.
  • the force required to push the stent-graft out of the delivery system may also be reduced, in that only the pleated edges of the graft make frictional contact with the inner surface of the delivery system.
  • One further advantage of the pleats is that blood tends to coagulate generally uniformly in the troughs of the pleats, discouraging asymmetric or large clot formation on the graft surface, thereby reducing embolus risk.
  • the graft material may also include one or more, and preferably a plurality of, radially oriented pleat interruptions 70.
  • the pleat interruptions are typically substantially circular and arc oriented perpendicular to longitudinal axis.
  • Pleat interruptions 70 allow the graft and prosthesis to bend better at selective points . This design provides for a graft material that has good crimpability and improved kink resistance.
  • the graft material as described above is preferably highly compressible, which also promotes a low crimped profile for better delivery characteristics.
  • the graft material may be impervious or substantially impervious to the flow of blood, or may be porous.
  • a graft material is impervious if it prevents blood from passing through the graft material on contact with blood or after the graft material is saturated with blood.
  • Choice of the flow characteristics of a graft material are well known to those skilled in the art, and are tied in part to the intended function of the prosthesis or portion of the prosthesis. For example, it may be desirable for the graft material that forms the cover of the first prosthesis to be impervious or substantially impervious to the flow of blood. Alternately, it may be desirable for a graft material to be porous or partially porous to promote biofusion.
  • the gasket member be substantially impervious to the flow of blood, at least when in a partially compressed state.
  • materials which are substantially impervious to the flow of blood include materials which become substantially impervious to the flow of blood after being saturated with blood.
  • the foregoing graft materials can be knitted or woven, and can be warp or weft knitted. If the material is warp knitted, it may be provided with a velour, or towel like surface, which is believed to speed the formation of blood clots, thereby promoting the integration of a prosthesis or prosthesis component into the surrounding cellular structure.
  • a graft material can be attached to a stent or to another graft material by any number of structures or methods known to those skilled in the art, including adhesives, such as polyurethane glue; a plurality of conventional sutures of polyvinylidene fluoride, polypropylene, polyester, or any other suitable material; ultrasonic welding; mechanical interference fit; and staples.
  • adhesives such as polyurethane glue
  • ultrasonic welding such as ultrasonic welding; mechanical interference fit; and staples.
  • a stent preferably has a graft member attached thereto.
  • the graft member covers at least a portion of the interior or exterior of the stent, and most preferably covers substantially all of the exterior of the stent.
  • third prosthesis 11a, b includes graft material 60 that covers only a portion of the distal end 42 of matrix 40. See, for example, Figure 4.
  • graft material may not be utilized on either end of the stent.
  • both ends thereof may be left uncovered.
  • the body has the ability to cover the exposed portions of the stent with endothelial cells and thus these exposed portions become endothelialised or incorporated into the vessel wall. This may be an important factor in the long term stability of the system. Essentially, over long periods of time, the aneurysmal sac can and will shrink if it is totally excluded from blood flow. This shrinkage changes the morphology of the aortic region that has been treated with the bypass prostheses. If all ends of the system are firmly anchored in the actual vessel, as is the case when the ends are covered with endothelium cells, the system will be better able to withstand these morphological changes.
  • a graft material that limits or eliminates the amount of blood that passes between the graft and the arterial wall, to provide a catheter-delivered graft or prosthesis that extends through a longer portion of an artery, to improving the anchoring mechanisms between two prostheses, to improving the anchoring mechanism between the prosthesis and the arterial wall or an interluminal cavity within an artery, and to improve the fluid dynamic and performance characteristics of the implanted prosthesis.
  • a stent and/or prosthesis of the present invention may include one or more markers.
  • one or markers may be positioned on the stent, the graft material, or on the prosthesis.
  • the markers arc used to identify the position of the stent or prosthesis in relation to a body part and/or in relation to another stent or prosthesis, and/or to identify the position of one part of the prosthesis relative to another part.
  • the marker(s) is used to identify a position in vivo.
  • a stent such as stents 12 and/or 40, preferably includes one or more radiopaque markers 15.
  • markers 15 Exemplary materials for forming markers include but are not limited to tantalum, platinum, iridium, and gold.
  • markers 15 are coils of radiopaque metal, wrapped around the struts of the stent. Markers 15 are preferably made from 0.19 mm (0.0075 inch) diameter tantalum (Ta) wire wrapped tightly around the struts.
  • the number, location, and size of the marker may vary, and the markers may be used alone or in combination to identify the position of a particular portion of the prosthesis.
  • a proximal marker adjacent aperture 32 may be 5 mm long and the proximal marker adjacent hole 33 may be 2 mm long.
  • two distal markers may be one hundred eighty degrees apart, and a proximal marker may be positioned equidistant from each of the distal markers. In this exemplary configuration, the proximal marker then aids proper rotational positioning of the device.
  • a prosthesis according to the present invention may include one or more connectors.
  • the connectors are used to engage or connect one prosthesis or component to another.
  • the connectors may be used to attach the gasket material or graft material to a stent or lattice.
  • exemplary connectors include but are not limited to sutures, staples, rivets, or the like.
  • the connector is a suture or staple, even more preferably, having a knotted or nub end.
  • a connector may be formed from a radiopaque material or a fluorescent material, each of which allow the connector to be used as a marker.
  • a connector adapted for use with a lattice-like stent As illustrated in Figure 4, a first connector 54 may be configured for use at an end portion of a stent, preferably at an end portion of a strut 44. A second connector 56 may be configured for use at an internal portion of a stent, preferably at the junction between two struts 44.
  • a connector assembly for receiving a rivet, staple, suture, or the like may include two apertures, each aperture configured to receive a leg of the rivet, staple, suture, or the like.
  • the end of each leg is preferably formed into a knot, nub, or spherical end that is of larger diameter than the diameter of the aperture.
  • the legs are passed through the apertures, and the end of each leg is formed into a nub.
  • one end may be formed into a nub prior to placement through the aperture, with the second end being formed into a nub after assembly of all the elements.
  • the structures and functions of the second connector 56 are similar or the same as those described above for the first connector.
  • the number of connectors and staples are typically dictated by the size and structure of a particular stent; it is intended that the invention should not be limited thereby.
  • the stent may include six first connectors and three second connectors.
  • the above staple aperture design or connector assembly has many advantages for attaching gasket material or a graft material to a stent. Because the legs of the staple are folded around and imbedded within a pocket or the like, any risk of puncturing an inflation balloon is minimized. In addition, the structural integrity of the prosthesis is increased because staples more securely attach the graft material to the stent, as compared to prior art designs which use suture or adhesives to attach the graft to the stent.
  • Staples 90 and 120 may be made from any number of materials known in the art, including tantalum alloys, platinum alloys or stainless steel, such as a grade of type 316 stainless steel.
  • the staples may take on other configurations and shapes, and can be coated for lubricity purposes.
  • the staples may be formed from a radiopaque material to identify the location of the staple, and to act as a marker to identify the location of a portion of the prosthesis. Using a different number of radiopaque staples on a distal end of a stent as compared to a proximal end further assists in identifying the position of the prosthesis.
  • the prosthesis of the invention can be used in a method in which includes delivering and positioning a system or component of a system in a fluid conduit, such as an aorta.
  • a fluid conduit such as an aorta.
  • the components described above permit intraluminal delivery into an aorta. This is accomplished by percutaneously inserting the prostheses into the same or different arteries, e.g., a femoral artery, and navigating them to the site of the aneurysm. This type of procedure is similar to delivery of angioplasty catheters and guiding catheters into the human vasculature.
  • the system components may be deployed either through a radially, outwardly extending force, e.g., expanding a balloon, or, if a self-expanding stent, by releasing the stent anchors from a constraint.
  • a radially, outwardly extending force e.g., expanding a balloon
  • a self-expanding stent by releasing the stent anchors from a constraint.
  • at least one passageway is formed bypassing the aneurysm. As shown in Figure 1, it may be desirable to form two fluid flow paths bypassing the aneurysm, each fluid flow path extending into a separate downstream artery.
  • the first prosthesis and second prosthesis can expand automatically against the wall of the artery. As the prosthesis expands, proximal longitudinal legs anchor the stent gasket in place.
  • the method also includes delivering and positioning at least one third prosthesis.
  • the third prosthesis is a bypass conduit for extending through an aneurysm.
  • the proximal end of the third prosthesis is typically positioned within the first prosthesis, preferably into and through a hole in the first prosthesis cover or gasket.
  • the distal end of the third prosthesis is typically positioned within the second prosthesis, preferably into and through a hole in the second prosthesis cover or gasket.
  • the hole is slightly smaller in diameter than the expanded diameter of the third prosthesis, thus sealingly engaging the third prosthesis in the first and second prostheses.
  • the sealed configuration of the third prosthesis within the first and second prostheses forms a fluid pathway through the assembly or system, thereby bypassing the aneurysm.
  • Figures 1 and 5 generally show how the system of the present invention may be deployed in vivo .
  • a typical delivery device such as a catheter, includes a guidewire 200 or the like that passes through an aperture in the cover of the first prosthesis, and a collar or the like that releasably engages at least one anchor on the prosthesis. Once the anchors are released from the collar, the first prosthesis can expand, preferably automatically. The portion of the delivery device containing the collar can then be removed from the artery, typically leaving the guidewire in place, i.e., still positioned in an aperture of the first prosthesis cover. The guidewire can then be used to guide another prosthesis or prostheses, such as a second prosthesis, into position.
  • the collar of the delivery device, engaged to the prosthesis may be positioned within a sheath or the like until the prosthesis is delivered. A portion of the prosthesis may be partially deployed and/or positioned. Once it is determined that the prosthesis is in its proper position, the collar can be pushed out of the sheath, thereby releasing the anchors from the collar. If the prosthesis is a self-expanding prosthesis, release of the flanges will allow the prosthesis to deploy automatically. If the prosthesis is not self-expanding, a deflated balloon or the like may be delivered to the interior of the prosthesis using the guidewire. When the balloon is inflated, it will expand the prosthesis into its fully deployed position, i.e., fully expanded radially.
  • a system of the present invention may be delivered as a unit, or may be delivered as components or separate prostheses and assembled in vivo .
  • the first and second prostheses are delivered first, either as a unitary element or separately.
  • One or more third prostheses may then be delivered sequentially.
  • precisely placing a component(s) of the system may be critical.
  • the physician must have precise placement of the components to ensure adequate repair of the aneurysm.
  • the present invention allows the physician to fully deploy a component within the body without fully releasing the entire component from the delivery device.
  • the anchors releasably interlock with complementary structures, such as grooves, on the delivery device, and, if the physician decides that the placement of the component is incorrect, the outer member of the delivery device may be moved relative to an inner member, thereby resulting in the prosthesis being retrieved or retracted within the delivery device.
  • the extended legs and anchors allow the physician to temporarily position the prosthesis before full deployment. Once the physician is satisfied with a prosthesis' position, the legs 20 may be released from their engagement with the delivery device.
  • a releasable stop may be preferably placed on the delivery device.
  • first prosthesis 10a After proper delivery, first prosthesis 10a, second prosthesis 10b, and third prostheses 11a and 11b should appear as they do in Figure 1.
  • First prosthesis 10a, along with its attached gasket material 30, is firmly secured within an arterial section upstream of an aneurysm.
  • a system and method for bypassing an aneurysm may establish one, and possible multiple, fluid flow paths through the system.
  • the system When the system is placed in an artery upstream of a junction with one or more other arteries, the system permits fluid, such as blood, to flow through the proximal end of the system, and a portion of the blood may flow out of the system into one of the cross arteries. Another portion of the fluid will continue within the system, bypassing the aneurysm and out of the system into one or more downstream arteries.
  • a method of the present invention therefore includes establishing one or more fluid flow paths.
  • the method includes establishing a first fluid flow path through the system, wherein the first fluid flow path bypasses the aneurysm.
  • the method may further include establishing at least one second fluid flow path, wherein the second fluid flow path passes through a portion of the system, and passes out of an intermediate portion of the system into an artery or arteries.
  • balloons may be utilized for tacking them into position if necessary.

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EP03250107A 2002-01-08 2003-01-08 Thoracic aneurysm repair prosthesis and system Expired - Lifetime EP1325716B1 (en)

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US8317856B2 (en) 2007-03-05 2012-11-27 Endospan Ltd. Multi-component expandable supportive bifurcated endoluminal grafts and methods for using same
US8709068B2 (en) 2007-03-05 2014-04-29 Endospan Ltd. Multi-component bifurcated stent-graft systems
US8486131B2 (en) 2007-12-15 2013-07-16 Endospan Ltd. Extra-vascular wrapping for treating aneurysmatic aorta in conjunction with endovascular stent-graft and methods thereof
US8979892B2 (en) 2009-07-09 2015-03-17 Endospan Ltd. Apparatus for closure of a lumen and methods of using the same
US8945203B2 (en) 2009-11-30 2015-02-03 Endospan Ltd. Multi-component stent-graft system for implantation in a blood vessel with multiple branches
US12127929B2 (en) 2009-11-30 2024-10-29 Endospan Ltd. Multi-component stent-graft system for implantation in a blood vessel with multiple branches
US9101457B2 (en) 2009-12-08 2015-08-11 Endospan Ltd. Endovascular stent-graft system with fenestrated and crossing stent-grafts
US8956397B2 (en) 2009-12-31 2015-02-17 Endospan Ltd. Endovascular flow direction indicator
US9486341B2 (en) 2011-03-02 2016-11-08 Endospan Ltd. Reduced-strain extra-vascular ring for treating aortic aneurysm
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US9427339B2 (en) 2011-10-30 2016-08-30 Endospan Ltd. Triple-collar stent-graft
US9597204B2 (en) 2011-12-04 2017-03-21 Endospan Ltd. Branched stent-graft system

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JP2003230579A (ja) 2003-08-19
US20020058985A1 (en) 2002-05-16
CA2415818C (en) 2010-06-15
MXPA03000270A (es) 2005-02-14
CA2415818A1 (en) 2003-07-08
AU2002320658B2 (en) 2008-02-14
ATE378021T1 (de) 2007-11-15
DE60317384D1 (de) 2007-12-27
DE60317384T2 (de) 2008-09-11
JP4397594B2 (ja) 2010-01-13
EP1325716A1 (en) 2003-07-09
US7229472B2 (en) 2007-06-12

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